The present invention relates to a heartburn and reflux disease treatment apparatus and mehtod. More specifically, the invention relates to a heartburn and reflux disease treatment apparatus and method for surgical application in the abdomen of a patient for forming a restricted food passageway in the esophagus or stomach. The term xe2x80x9cpatientxe2x80x9d includes an animal or a human being.
Chronic heartburn and reflux disease is a widespread medical problem. This is often due to hiatal hernia, i.e. a portion of the stomach immediately below the gastric fundus slides upwardly through the esophageal hiatus. In consequence, stomach acids and foods are regurgitated into the esophagus.
In the late 1970s a prior art prosthesis called Angelchik, according to U.S. Pat. No. 3,875,928, was used to operatively treat heartburn and reflux disease. However, the Angelchik prosthesis had a major disadvantage in that it was not possible to adjust the size of the restriction opening after the operation. A further disadvantage was that the prosthesis did not satisfactorily protect the esophagus and the surrounding area against injuries due to poor shape of the prosthesis. Therefore, operations using the Angelchik prosthesis are no longer practiced.
An operation technique, semi-fundoduplicatio, is currently in use for treating heartburn and reflux disease. A most common operation is Nissen semi-fundoduplicatio, in which one takes the fundus of the stomach and makes a three quarter of a turn around the esophagus and suture between the stomach and esophagus. Although this operation works fairly well it has three main disadvantages. Firstly, most patients treated in accordance to xe2x80x9cad modum Nissenxe2x80x9d lose their ability to belch. Secondly, many of these patients get dysphagia, i.e. have difficulties in swallowing after the operation. Thirdly, it is not possible to adjust the food passageway in the esophagus or stomach in any way after the operation. Characteristic for these patients is the variation of their problems over the course of a day. For example, many patients have difficulties during the night when they lie down because of stomach acid leaking up into the esophagus.
The present invention relates to a heartburn and reflux treatment apparatus. More specifically, the invention relates to a heartburn and reflux treatment for surgical application in the abdomen of a patient for forming a food passageway in the esophagus or stomach having a restricted cross-sectional area. The term xe2x80x9cpatientxe2x80x9d includes an animal or a human being.
The object of the present invention is to provide a new heartburn and reflux disease treatment apparatus which permits post-operation adjustments that are comfortable for the patient.
Accordingly, the present invention provides a heartburn and reflux disease treatment apparatus comprising an adjustable restriction device implanted in the patient and engaging the stomach close to the cardia or esophagus to form a restricted cross-sectional area of the food passageway in the stomach or esophagus, and a post-operation adjustment device which mechanically adjusts the restriction device to change the size of the cross-sectional area. The post-operation adjustment device preferable adjusts the restriction device in a non-invasive manner. As a result, the restriction device performs like an artificial sphincter, which can be adjusted by the patient in connection with every food intake during the day, or possibly only in the morning to open up the food passageway and in the evening to close the food passageway.
The adjustment device may be incorporated in the restriction device as well as being controlled by hydraulic means. The expression xe2x80x9cpost-operation non-invasive adjustment devicexe2x80x9d means that the adjustment device is capable of adjusting the restriction device after the operation without the need for invasive measures, such as penetration of the skin for example by injection needles or surgery, or by any other means that penetrate the skin. Though an injection port could be used in embodiments using hydraulic means, the port preferably would be for enabling a single, once and for all, calibration of the amount of liquid contained by the hydraulic means. In this case, the injection port suitably is integrated in the reservoir.)
Generally the implanted restriction device comprises a holding device to prevent the region of the cardia to pass through the esophageal hiatus diaphragmatica. This could be achieved by an enlarged area that should pass the hole in the diaphragmatic muscle where the esophagus passes (a triangular opening surrounded by the crus muscles) or by fixing or holding the region of the cardia in place. The holding device may take the shape of a support member that provides a support for the restriction device upwardly against the diaphragm muscle or sutures or anything formed by human tissue. Alternatively, the restriction device itself could prevent the region of the cardia from sliding up. Means for narrowing the triangular opening could also be provided.
In all applicable embodiments, the restriction device may take any shape and be either hydraulic or non-inflatable. Suitably, the support member is soft.
Preferably, the restriction device comprises an elongated, suitably non-inflatable, restriction member and forming means for forming the restriction member into at least a substantially closed loop around the esophagus or stomach, the loop defining a restriction opening, whereby the adjustment device adjusts the restriction member in the loop to change the size of the restriction opening.
In the various embodiments hereinafter described the restriction member generally forms an at least substantially closed loop. However, the restriction member may take a variety of different shapes, such as the shape of a square, rectangle or ellipse. The restriction member in the substantially closed loop could for example be totally flat, like a belt. The shape of the restriction member may also be changed during use, by rotation or movment in any direction. A physical lumen, such as the passageway in the esophagus, is often easier to restrict by contracting at least two opposite or different side walls of the lumen against each other. Thus, the restriction member may be designed to perform such a contracting effekt of the opposite walls of the esophagus. Either mechanical or hydraulic solutions may be employed to operate the restriction member. Alternatively, the restriction member may comprise an adjustable cuff, a clamp or a roller for bending the esophagus to close or almost close its passageway. Such a cuff, clamp or roller may also be utilized for squeezing the esophagus against human material inside the body of the patient or against implanted structures of the apparatus.
In accordance with a preferred first adjustment principle, the adjustment device adjusts the longitudinal extension of the elongated restriction member in a loop form.
In a preferred embodiment of the invention utilizing the first adjustment principle, the restriction member comprises a main portion and two elongated end portions, and the adjustment device establishes longitudinal relative displacement between the end portions of the restriction member, so that the size of the restriction opening is adjusted. The forming means may comprise any suitable known or conventional device capable of practicing the desired function, such as a spring material forming the elongated restriction member into the loop, so that the restriction opening has a predetermined size, and the adjustment device may adjust the restriction member against the spring action of the spring material. In other words, the restriction member may comprise a spring clip. The spring material may be integrated in the restriction member.
Preferably, the adjustment device comprises a movement transferring member, suitably a drive wheel, in engagement with at least one of the end portions of the restriction member and operable to displace the one end portion relative to the other end portion of the restriction member. The drive wheel may advantageously be in engagement with both of the end portions of the restriction member and be operable to displace said end portions relative to each other. An elongated flexible drive shaft may be operatively connected to the drive wheel, for transferring manual or motor generated power from a location remote from the restriction member. In its simplest embodiment, the drive wheel may comprise a pulley in frictional engagement with the restriction member. As an alternative, a gear rack may be formed on at least one of the end portions of the restriction member and the drive wheel may comprise a gear wheel in mesh with the gear rack. Other suitable known or conventional mechanisms may also or alternatively be used as the adjustment means.
The movement transferring member may alternatively comprise at least one cylinder and a piston, which is movable therein and is connected to one of the end portions of the restriction member, the piston being operable to longitudinally displace the one end portion of the restriction member relative to the other end portion of the restriction member. Alternatively, the movement transferring means may comprise two interconnected cylinders and two pistons in the respective cylinders connected to said end portions, respectively, of the restriction member, the pistons being operable to longitudinally displace the end portions of the restriction member relative to each other. Other known or conventional devices also or alternatively can be used as the movement transferring member.
A motor, which is fixed relative to the main portion of the restriction member and has a rotating drive shaft operatively connected to the movement transferring member, may be positioned relative to the elongated restriction member such that the drive shaft extends transverse thereto. Alternatively, the motor may be positioned relative to the elongated restriction member such that the drive shaft extends substantially tangentially to the loop of the restriction member.
In another embodiment of the invention utilizing the first adjustment principle, the elongated restriction member is longitudinally resilient and the adjustment device comprises a contraction device for longitudinally contracting the resilient restriction member. Preferably, the elongated restriction member comprises a substantially nonresilient main portion and an end portion forming an elongated helical spring, which is contractable by the contraction device. The contraction device may suitably comprise an elongated flexible pulling member connected to the main portion of the restriction member and extending through the helical spring to contract the helical spring against an arresting member, which is fixed relative to the main portion of the restriction member. The pulling member may extend in an elongated tube joined at one end thereof to the arresting member, so that a motor remote from the restriction member may be attached to the other end of the elongated tube and pulls the pulling member through the tube to contract the helical spring.
In yet another embodiment of the invention utilizing the first adjustment principle, the elongated restriction member comprises an elongated helical spring having a free end, and a body to which the spring is nonrotatably secured at its opposite end. The adjustment device rotates the helical spring in one direction to enlarge the coils of the helical spring to longitudinally contract the spring and to rotate the spring in the opposite direction to reduce the size of the coils of the spring to longitudinally extend spring. As a preferred alternative, the restriction member comprises a further elongated helical spring having a free end and nonrotatably secured to the body at its opposite end, and the adjustment device comprises a drive shaft having two opposite end portions connected to the springs, respectively, at their free ends, the helical coils forming left and right hand helices, respectively. The adjustment device may alternatively comprise a gearing having an input shaft and two opposite aligned output shafts connected to the helical springs, respectively, at their free ends, the input shaft being connected to said output shafts so that the output shafts rotate in the opposite directions upon rotation of the input shaft, the helical coils forming the same helices.
In accordance with a second adjustment principle, the adjustment device mechanically adjusts the restriction member so that at least a portion of a radially innermost circumferential confinement surface formed by the restriction member is substantially radially displaced.
In one embodiment of the invention utilizing said second adjustment principle, the restriction member comprises an elongated voltage responsive element forming part of the confinement surface and capable of bending into a bow in response to a voltage applied across the element, the radius of curvature of the bow being adjustable by changing the level of the voltage.
In another embodiment of the invention utilizing said second adjustment principle, the adjustment device changes the diameter of an elastic annular element of the restriction member, which forms the confinement surface. Preferably, the forming means comprises a substantially rigid outer annular element coaxially surrounding the elastic annular element, and the adjustment device comprises means for pulling the elastic annular element radially outwardly towards the outer annular element to expand the elastic annular element. For example, the pulling means may comprise a plurality of threads secured to the elastic annular element along the circumference thereof and running from the elastic annular element via guide members attached to the outer annular element.
In yet another embodiment of the invention utilizing said second adjustment principle, the forming means comprises a substantially rigid outer annular element, and the restriction member comprises an elongated helical spring extending internally along the outer annular element and contacting the latter. The helical spring forms part of the circumferential confinement surface and has a free end. The restriction member further comprises a body to which the spring is nonrotatably secured at its opposite end. The adjustment device rotates the helical spring in one direction to enlarge the coils of the spring to contract the circumferential confinement surface and rotates the spring in the opposite direction to reduce the size of the coils of the spring to expand the circumferential confinement surface. As an alternative, which is preferred, the restriction member comprises two elongated helical springs forming part of the circumferential confinement surface and connected to the body of the restriction member. The adjustment device rotates each spring in one direction to enlarge the coils of the spring to contract the circumferential confinement surface and rotates the spring in the opposite direction to reduce the size of the coils of the spring to expand the circumferential confinement surface.
In accordance with a third adjustment principle, the restriction member comprises at least two separate elements, at least one of which is pivoted so that it may turn in a plane in which the the restriction member extends, and the adjustment device turns the pivoted element to change the size of the restriction opening. Preferably, the restriction member comprises a plurality of separate pivoted elements disposed in series, each pivoted element being turnable in the plane, and the adjustment device turns all of the pivoted elements to change the size of the restriction opening. For example, the pivoted elements may comprise lamellae arranged like the conventional adjustable aperture mechanism of a camera.
In accordance with a fourth adjustment principle, the adjustment device folds at least two foldable frame elements of the restriction member towards each other. Preferably, the foldable frame elements comprise two substantially or partly semi-circular frame elements which are hinged together so that the semi-circular elements are swingable relative to each other from a fully open state in which they form part of a circle to a fully folded state in which they form part of a semi-circle. The same principal may be used with the swingable parts mounted together in one end and not in the other end. Alternatively, the restriction device may comprises at least one preferable two preferable rigid articulated clamping elements positioned on opposite sides of the esophagus or stomach, and the adjustment device turns the clamping elements toward each other to clamp the esophagus or stomach between the clamping elements, thereby decreasing said area, and turns the clamping elements away from each other to release the elements from the esophagus or stomach, thereby increasing said area.
In accordance with a fifth adjustment principle, the adjustment device turns the restriction member around a longitudinal extension thereof, the elongated restriction member being elastic and varying in thickness as seen in a cross-section therethrough. Suitably, the elongated restriction member comprises an elastic belt.
In accordance with a sixth adjustment principle, the adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is changed.
In accordance with a seventh adjustment principle, the adjustment device changes the size of said restriction opening such that the outer circumferential confinement surface of said restriction member is unchanged.
In accordance with an eighth adjustment principle, the elongated restriction member is flexible, and the adjustment device pulls a first portion of the flexible restriction member from a second portion of the flexible restriction member opposite the first portion in the loop to squeeze the esophagus or stomach between two opposite lengths of the elongated flexible restriction member to decrease the cross-sectional area in the esophagus or stomach and releases the esophagus or stomach from the flexible restriction member to increase the cross-sectional area.
In accordance with a ninth adjustment principle, the restriction device comprises at least two elements on different sides of the esophagus or stomach, and the adjustment device squeezes the esophagus or stomach between the elements to decrease the cross-sectional area in the esophagus or stomach and releases the esophagus or stomach from the elements to increase the cross-sectional area. In all applicable embodiments, the restriction device may have any shape or form and be either hydraulic or non-inflatable.
In accordance with a tenth adjustment principle, the restriction device bends a portion of the esophagus or stomach and comprises at least two displacement members positioned on opposite or different sides of the esophagus or stomach and spaced apart along the food passageway in the esophagus or stomach, wherein the adjustment device moves the displacement members towards the esophagus or stomach to bend the latter, thereby reducing said area, and away from the esophagus or stomach to release them from the displacement members, thereby increasing said area. Suitably, the displacement members comprise rollers. The restriction device may also rotate a portion of the esophagus or stomach. The bending or rotating members may have any shape or form and be either hydraulic or non-inflatable.
The retriction device may comprise two different holders, one placed more distal than the other, forming two at least substantially closed loops. The holders may be rotated in opposite directions to each other. With interconnecting means, for example flexible bands between the different holders, a restriction will occur between the holders when they are rotated.
In all of the above-described embodiments of the invention the adjustment device is conveniently operated by any suitable motor, preferably an electric motor, which may be fixed directly to or be placed in association with the restriction member, or alternatively be located remote from the restriction member, advantageously in the abdomen or subcutaneously. In the latter alternative the motor is advantageously connected to the adjustment device by a flexible power transmission conduit to permit a suitable positioning of the motor in the abdomen of the patient. The motor may be manually activatable, for example by an implanted switch.
In some of the above described embodiments of the invention, however, the adjustment device may conveniently be operable by a hydraulic operation device, which preferably is manually activatable. The hydraulic operation device may advantageously include hydraulic servo means to facilitate manual activation. As an alternative, the hydraulic device may be powered by an electric motor, which may be manually activatable or controlled by remote control means. The components of such a hydraulic operation device may be placed in association with the restriction member and/or be located at a suitable place in the abdomen or subcutaneously.
More specifically, a reservoir may be provided containing a predetermined amount of fluid for supplying the hydraulic operation device with fluid. The reservoir defines a chamber for the predetermined amount of fluid and the hydraulic operation device changes the size of the chamber. The hydraulic operation device may comprise first and second wall portions of the reservoir, which are displaceable relative to each other to change the size of the chamber of the reservoir. The first and second wall portions of the reservoir may be designed to be displaceable relative to each other by manual manipulation thereof, preferably to permit manual pushing, pulling or rotation of any of the wall portions in one direction. Alternatively, the wall portions may be displaceable relative to each other by magnetic means (such as a permanent magnet and magnetic material reed switch, or other known or conventional magnetic devices), hydraulic means or electrical control means such as an electric motor. The magnetic means, hydraulic means, or electrical control means may all be activated by manual manipulation, preferably using a subcutaneously located manually manipulatable device. This control may be indirect, for example via a switch.
The hydraulic operation device may operate the adjustment device with fluid from the reservoir in response to a predetermined first displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir, to increase the size of the restriction opening, and to operate the adjustment device with fluid from the reservoir in response to a predetermined second displacement of the first wall portion of the reservoir relative to the second wall portion of the reservoir, to decrease the size of the restriction opening. In this embodiment, no pump is used, only the volume of the reservoir is varied. This is of great advantage compared to the solution described below when a pump is used to pump fluid between the reservoir and the adjustment device because there is no need for a non-return valve and it is still possible to have fluid going both to and from the reservoir.
As an alternative, the hydraulic operation device may comprise an activatable pump for pumping fluid between the reservoir and the adjustment device. The pump may pump fluid both to and away from the adjustment device, or hydraulic means controlling the adjustment device. A mechanical manual solution is proposed in which it is possible to pump in both directions just by pushing an activating member in one direction. Another alternative is a pump pumping in only one direction and an adjustable valve to change the direction of fluid to either increase or decrease the amount of fluid in the reservoir. This valve may be manipulated manually, mechanically, electrically, magnetically, or hydraulically. Any kind of motor could of course be used for all the different operations as well as wireless remote solutions. The pump may comprise a first activation member for activating the pump to pump fluid from the reservoir to the adjustment means and a second activation member for activating the pump to pump fluid from the adjustment device to the reservoir. The activation members may be operable by manual manipulation, preferably to permit manual pushing, pulling or rotating thereof in one direction. Suitably, at least one of the activation members is adapted to operate when subjected to an external pressure exceeding a predetermined magnitude.
Alternatively, at least one of the first and second activating members may be operable by magnetic means, hydraulic means or electrical control means such as an electric motor. The magnetic means, hydraulic means, or electrical control means may all be activated by manual manipulating means preferably located subcutaneously. This activation may be indirect, for example via a switch.
Advantageously, especially when manual manipulation means are used, a servo system could be used. With servo means less force is needed for controlling the adjustment device. Hydraulic means is preferably used with servo means. One example is a closed system that controls another closed system in which the hydraulic devices of the adjustment device is incorporated. Minor changes in the amount of fluid in a reservoir of the first system could then lead to major changes in the amount of fluid in a reservoir in the second system. In consequence, the change of volume in the reservoir of the second system affects the hydraulic device of the adjustment device, which is incorporated in the second closed system. The great advantage of this servo system is that the larger volume system could be placed inside the abdomen where there is more space and still would be possible to use manual manipulation means of the smaller system subcutaneously. The servo reservoir could control the reservoir of the larger volume. The servo reservoir could be controlled directly or indirectly by a fluid supply means. The fluid supply means may be a small reservoir, which may be placed subcutaneously and may be activated by manual manipulation means controlling the servo reservoir.
Preferably, the servo means comprises hydraulic means and a servo reservoir and eventually a fluid supply reservoir. Both reservoirs define a chamber containing servo fluid, and the hydraulic means comprises first and second wall portions of the servo reservoir, which are displaceable relative to each other to change the size of the chamber of the servo reservoir. The hydralic means may control the adjustment device indirectly, e.g. via an increased amount of fluid in the servo reservoir, in response to a predetermined first displacement of the first wall portion of any of the reservoirs relative to the second wall portion of the reservoir to decrease the size of the restriction opening, and to control the adjustment device in response to a second displacement of the first wall portion of any reservoir relative to the second wall portion, to indirectly increase the size of the restriction opening. The wall portions of the reservoirs may be designed to be displaceable relative to each other by manual manipulation thereof or be displaceable relative to each other by manually pushing, pulling or rotating any of the wall portions of the reservoir in one direction. Alternatively, the wall portions of the servo reservoir may be displaceable relative to each other by magnetic means, hydraulic means or electric control means including an electric motor.
The magnetic means, hydraulic means, or electrical control means may all be activated by manually manipulated means preferably located subcutaneously. This control may be indirect for example via a switch.
Even in the broadest embodiment of the invention the adjustment device may comprise a servo means. The servo means may comprise a hydraulic operation means, an electrical control means, a magnetic means, mechanical means or a manual manipulation means. The hydraulic operation means, electrical control means, mechanical means or magnetic means may be activated by manual manipulating means. Using a servo system will save the use of force when adjusting the adjustment device which may be of importance in many applications, for example when a battery cannot put out enough current although the total energy in the battery is more than enough to power the system.
The hydraulic fluid used by the operation device in any of the above embodiments may be of a kind that changes viscosity when it is exposed to energy different from thermal energy. For example, the viscosity of the hydraulic fluid may change when the fluid is exposed to electric energy. It should be understood that the word fluid also could incorporate gas or air in all applications.
All solutions may be controlled by a wireless remote control for non-invasively controlling the adjustment device. The remote control may advantageously be capable of obtaining information on the size of the restriction opening or other information related to the implanted components of the apparatus and to command the adjustment device to adjust the restriction member in response to obtained information. With the remote control the apparatus of the invention is conveniently controlled to adjust the implanted restriction device, which controls the cross-sectional area of the food passageway and wherein the restriction device is operable to open and close the food passageway. The restriction device may steplessly controls the cross-sectional area of the food passageway.
The apparatus according may further comprise a pressure sensor for directly or indirectly sensing the pressure against the restriction device and the control device may control the restriction device in response to signals from the pressure sensor. The post-operation adjustment device preferable non-invasively adjusts the restriction device to change the size of the cross-sectional area. The pressure sensor may be any suitable known or conventional pressure sensor such as shown in U.S. Pat. Nos. 5,540,731, 4,846,181, 4,738,267,4,571,749, 4,407,296 or 3,939,823; or an NPC-102 Medical Angioplasty Sensor.
The apparatus may further comprise an implanted energy transfer device for transferring wireless energy directly or indirectly into kinetic energy for operation of the restriction device.
The remote control permits adjustment of the implanted restriction device any time after the operation, so that the patient may get rid of problems with belching, swallowing etc. The patient can conveniently open up the restriction opening somewhat more when eating and close the restriction opening at night, when going to bed. This new adjustment procedure available to a patient provided with the apparatus of the invention is a great advantage compared to the prior art.
The remote control comprises means for wireless transfer of energy from outside the patient""s body to energy consuming implantable components of the device. A motor may suitably be implanted in the patient for operating the adjustment device and the means for wireless transfer of energy may directly power the motor with transferred energy. The energy transferred by the means for transfer of energy may comprise any kind of signals including wave signals, an electric field or a magnetic field.
The wireless remote control comprises an external signal transmitter and/or receiver and an implanted signal receiver and/or transmitter. For example, the signal transmitter and signal receiver(transceivers may be used) may transmit and receive a signal in the form of digital pulses, which may comprise a magnetic or electric field. Alternatively, which is preferred, the signal transmitter and signal receiver may transmit and receive a signal, which comprises an electromagnetic wave signal, a sound wave signal or a carrier wave signal for remote control signals. The receiver may comprise a control unit for controlling the adjustment device in response to a control signal from the signal transmitter.
The apparatus of the invention may further comprise an implanted energizer unit for providing energy to implanted energy consuming components of the apparatus, such as electronic circuits and/or a motor for operating the adjustment device. The control unit may power such an implanted motor with energy provided by the energizer unit in response to a control signal received from the signal transmitter. Any known or conventional signal transmitting or signal receiving device that is suitable for use with a human or mammal patient may be provided as the signal transmitter or signal receiver. The control signal may comprise an electromagnetic wave signal, such as an infrared light signal, a visible light signal, a laser light signal, a micro wave signal, or a sound wave signal, such as an ultrasonic wave signal or an infrasonic wave signal, or any other type of wave signals. The control signal may also comprise electric or magnetic fields, or pulses. All of the above-mentioned signals may comprise digital signals. The control signal may be carried by a carrier signal, which may be the same as the wireless energy signal. Preferably, a digital control signal may be carried by an electromagnetic wave signal. The carrier signal or control signal may be amplitude or frequency modulated.
The motor may be any type of motor, such as a pneumatic, hydraulic or electric motor and the energizer unit may power the motor with pressurized gas or liquid, or electric energy, depending on the type of motor. Where the motor is an electric motor, it may power pneumatic or hydraulic equipment.
The energizer unit may comprise a power supply and the control unit may power the motor with energy from the power supply. Preferably, the power supply is an electric power supply, such as a battery, and the motor is an electric motor. In this case, the battery also continuously powers at least a part of the circuitry of the signal receiver in a standby mode between the adjustment operations, in order to keep the signal receiver prepared for receiving signals transmitted from the signal transmitter.
The energizer unit may transfer energy from the signals, as they are transmitted to the signal receiver, into electric energy for powering the implanted electronic components. For example, the energizer unit may transfer the energy from the signals into a direct or alternating current.
In case there is an implanted electric motor for operating the adjustment device the energizer unit may also power the motor with the transferred energy. Advantageously, the control unit directly powers the electric motor with electric energy, as the energizer unit transfers the signal energy into the electric energy. This embodiment is particularly simple and does not require any recurrent invasive measures for exchanging empty power supplies, such as batteries, that is required in the first embodiment described above.
For adjustment devices of the type that require more, but still relatively low, power for their operation, the energizer unit may comprise a rechargeable electric power supply for storing the electric energy obtained and the control unit may power the electric motor with energy from the rechargeable electric power supply in response to a control signal received from the signal transmitter. In an initial charging step the rechargeable power supply can be charged over a relatively long time (e.g. a few seconds up to a half hour) without powering the electric motor. In a following operating step, when the power supply has been charged with sufficient energy, the control unit powers the electric motor with energy from the charged power supply to operate the adjustment device, so that a desired change of the cross-sectional area of the food passageway is achieved. If the capacity of the power supply is insignificant to achieve the necessary adjustment in one single operating step, the above steps may conveniently be repeated until the desired adjustment is achieved.
The electric power supply suitably comprises an inexpensive simple capacitor. In this case, the electric motor may be a stepping motor. In all cases the motor may preferable be able to perform a reversing function.
The signal transmitter may transmit an electromagnetic control signal and the energizer unit may draw radiant energy from the electromagnetic wave signal, as the latter is transmitted to the signal receiver, and may transfer the radiant energy into electric energy. Alternatively, the energizer unit may comprise a battery, an electrically operable switch for connecting the battery to the signal receiver in an on mode when the switch is powered and for keeping the battery disconnected from the signal receiver in a standby mode when the switch is unpowered, and a rechargeable electric power supply for powering the switch. The control unit may power the electric motor with energy from the battery in response to a control signal received from the signal transmitter, when the switch is in its on mode. Advantageously, the energizer unit may transfer wave energy from the control signal, as the latter is transmitted to the signal receiver, into a current for charging the rechargeable electric power supply, which suitably is a capacitor. Energy from the power supply is then used to change the switch from off (standby mode) to on. This embodiment is suited for adjustment devices of the type that require relatively high power for their operation and has the advantage that the electronic circuitry of the signal receiver does not have to be powered by the battery between adjustments. As a result, the life-time of the battery can be significantly prolonged. The switch may be switched with magnetic, manual or electric energy.
As an example, the signal transmitter may transmit an electromagnetic wave signal and the energizer unit may draw radiant energy from the electromagnetic wave signal, as the latter is transmitted to the signal receiver, and may transfer the radiant energy into electric current. The energizer unit suitably comprises a coil of the signal receiver for inducing an alternating current as the electromagnetic wave signal is transmitted through the coil and a rectifier for rectifying the alternating current. The rectified current is used for charging the rechargeable power source.
Alternatively, the signal transmitter and receiver may solely be used for control signals and a further pair of signal transmitter and receiver may be provided for transferring signal energy to implanted components. By such a double system of signal transmitters and receivers the advantage is obtained that the two systems can be designed optimally for their respective purposes, namely to transmit control signals and to transfer energy from signals. Accordingly, the apparatus may further comprise an external energy transmitter for transmitting wireless energy, wherein the energizer unit comprises a battery and an operable switch for connecting the battery to the signal receiver in an on mode when the switch is powered and to keep the battery disconnected from the signal receiver in a standby mode when the switch is unpowered, the external energy transmitter for powering said switch. Suitably, the energy transmitter may directly power the switch with the wireless energy to switch into the on mode. As should be realized by a skilled person, in many of the above-described embodiments of the invention the adjustment device may be operated by control means or manual manipulation means implanted under the skin of the patient, such as a pump, an electrical switch or a mechanical movement transferring means. In the manual embodiment it is not necessary to use a motor for operating the adjustment device.
In embodiments including hydraulic transmission means, an injection port connected to the hydraulic means may be provided for enabling, normally single, once-and-for-all, calibration of the amount of fluid in the hydraulic system.
In all applications a motor may be operatively connected to the adjustment device and wherein the control of the motor may comprise a reversing device implanted in the patient for reversing the motor. Where the restriction device is capable of performing a reversible function, the reversing device may also reverse the function performed by the restriction device.
In all applications the adjustment device preferable adjusts the restriction device in a non-manual manner without touching the skin of the patient.
The invention also comprises a method for treating heartburn and reflux disease, comprising(a) surgically implanting in the abdomen of a patient suffering from heartburn and reflux disease an adjustable restriction device which forms a food passageway having a restricted cross-sectional area in the esophagus or in the stomach close to the cardia, and (b) when necessary for the patient""s health or desired progress, in a non-invasive procedure mechanically adjusting the restriction device to change the size of the cross-sectonal area of the food passageway.
The adjustment device may in all cases be mechanically operated and/or operated in a non-manual manner and be energised by the provision of a source of energy from which energy is released by control means from outside the patient""s body to energise the adjustment and/or restriction device.
The invention also provides a surgical method for laparascopically implanting an adjustable restriction device of a heartburn and reflux disease treatment apparatus for forming a food passageway having a restricted cross-sectional area in the esophagus or stomach immediately close to the cardia, the method comprising: (a) Insufflating the abdomen of a patient to form a pneumoperitoneum. (b) Introducing at least one laparascopic trocar into the abdomen. (c) Using a dissecting tool inserted through the laparascopic trocar, dissecting the region of the esophagus or stomach adjacent or above the bursa omentalis. And (d) introducing the restriction device in the abdomen and applying the device on the esophagus or stomach. This method may further comprise after (a)-(d), (e) post-operatively adjusting the restriction device in a non-invasive procedure to change the cross-sectional area of the food passageway.
It is the primary object of the present invention to provide an advantageously yet relatively simple apparatus and method for treating heartburn and reflux disease in a substantially non-invasive manner after initial surgical implantation of a restriction device. This and other objects will become clear from the detailed description and from the appended claims.